Ultrasound catheter and methods for making and using same

ABSTRACT

Ultrasound catheter devices and methods provide enhanced disruption of blood vessel obstructions. Generally, ultrasound catheters include an elongate flexible catheter body with one or more lumens, an ultrasound transmission member extending longitudinally through the catheter body lumen and, in some embodiments, a guidewire tube extending through the lumen. A distal head for disrupting occlusions is coupled with the distal end of the ultrasound transmission member and is positioned adjacent the distal end of the catheter body. Some embodiments include improved features such as a bend in the catheter body for enhancing positioning and/or advancement of the catheter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/538,009, filed Aug. 7, 2009, which is a continuation of U.S. patentapplication Ser. No. 10/345,078, filed on Jan. 14, 2003, now U.S. Pat.No. 7,604,608, which is related to U.S. patent application Ser. No.10/229,371, filed Aug. 26, 2002, now U.S. Pat. No. 7,137,963, the fulldisclosures of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTION

The present invention pertains to medical equipment, and moreparticularly, to a therapeutic ultrasound system for ablatingobstructions within tubular anatomical structures such as blood vessels.The ultrasound system includes a protective feature that minimizes theintroduction of debris into the patient's vasculature if the ultrasoundtransmission member were to break, fracture or become dislodged during amedical procedure.

The present invention relates generally to medical devices and methods.More specifically, the present invention relates to ultrasound catheterdevices, methods for making the devices, and methods for using thedevices to disrupt blood vessel occlusions.

Catheters employing various types of ultrasound transmitting membershave been successfully used to ablate or otherwise disrupt obstructionsin blood vessels. Specifically, ablation of atherosclerotic plaque orthromboembolic obstructions from peripheral blood vessels such as thefemoral arteries has been particularly successful. To disrupt occlusionsof small blood vessels, such as coronary arteries or peripheral vessels,ultrasound catheters typically have configurations—size, flexibility,shape and the like—which allow for their advancement through thetortuous vasculature of the aortic arch, coronary tree, peripheralvasculature or other similarly narrow vessels.

Typically, an ultrasound catheter transmits energy from an ultrasoundtransducer through a transducer horn and then a transmission member,such as a wire, to a distal tip or distal head. Ultrasound energypropagates through the transmission member as a sinusoidal wave to causethe distal head to vibrate. Such vibrational energy is typicallyutilized to ablate or otherwise disrupt vascular obstructions. Variousultrasonic catheter devices have been developed for use in ablating orotherwise removing obstructive material from blood vessels. For example,U.S. Pat. Nos. 5,267,954 and 5,380,274, issued to the inventor of thepresent invention and hereby incorporated by reference, describeultrasound catheter devices for removing occlusions. While manyultrasound catheters have been developed, however, improvements arestill being pursued.

To effectively reach various sites for treatment of intravascularocclusions, ultrasound catheters often have lengths of about 150 cm orlonger. To reach some sites, such as arterial side-branches, it is oftennecessary to form a bend in the ultrasound catheter. Such bends areoften crudely made in an operating room, vascular suite or other settingby a surgeon, cardiologist, interventional radiologist or otherphysician manually bending the catheter with pliers, surgical forceps orsome other instrument. This technique has several drawbacks. First, itis inaccurate and does not always result in a bend at a desired locationalong the catheter or in a bend having a desired angle. Second, becausethe user bends the catheter when the catheter is already assembled, withthe transmission member already in place, a strain is placed on thetransmission member by the bending process. The transmission member istypically bent to as acute of an angle as the catheter body is bent, andthe bending process itself stresses the transmission member. Even slightstresses placed on the transmission member by such a bending proceduremay cause the transmission member to break prematurely, leading to areduced usable life for the ultrasound catheter. This susceptibility forpremature breakage is compounded by the fact that currently availableultrasonic transmission wires typically break toward their distal ends,where the cross-sectional areas of the wires become smaller.

Therefore, a need exists for ultrasound catheter devices and methods formaking and using such devices that include at least one bend forenhancing positioning and/or advancement of the catheter in a bloodvessel. Ideally, such catheter devices would be durable enough to lastlonger than a conventional ultrasound catheter that is hand-bent by asurgeon or other user immediately before use. Ultrasound catheters mayalso benefit from additional improvements, such as over-the-wireconfigurations, improved configurations of a distal head of thecatheter, catheters that allow for various modes of operation, catheterswith enhanced lubricity and the like. At least some of these objectiveswill be met by the present invention.

BRIEF SUMMARY OF THE INVENTION

Ultrasound catheter devices and methods of the present invention provideenhanced disruption of blood vessel obstructions. Generally, ultrasoundcatheters include an elongate flexible catheter body with at least onelumen, an ultrasound transmission member extending longitudinallythrough the lumen and, in many embodiments, a guidewire tube extendingthrough the lumen. A distal head for disrupting occlusions is coupledwith the distal end of the ultrasound transmission member and ispositioned adjacent the distal end of the catheter body. Variousembodiments include novel features such as a bend in the catheter bodyto facilitate positioning and/or advancement of the catheter,over-the-wire configurations, improved configurations of a distal headof the catheter, catheters that allow for various modes of operation,catheters with enhanced lubricity and the like. Methods for makingultrasound catheters may include methods for making a bend in thecatheter, methods for sterilizing a catheter using electron-beamradiation and/or the like.

In one aspect of the invention, an ultrasound catheter for disruptingocclusions in blood vessels comprises an elongate flexible catheter bodyhaving a proximal end, a distal end, at least one lumen, and at leastone bend in the catheter body nearer the distal end than the proximalend. The catheter also includes an ultrasound transmission memberextending longitudinally through the lumen of the catheter body, theultrasound transmission member having a proximal end connectable to aseparate ultrasound generating device and a distal end disposed adjacentthe distal end of the catheter body. Finally, the catheter includes adistal head coupled with the distal end of the ultrasound transmissionmember, the distal head positioned adjacent the distal end of thecatheter body.

Generally, the bend in the catheter may be placed in any desiredlocation and have any desired angle, relative to the longitudinal axisof the catheter body. In some embodiments, for example, the bend in thecatheter body is disposed along the catheter body at a location between5 mm and 30 mm from the distal end. In some embodiments, the bend in thecatheter body has an angle of less than 90 degrees. For example, thebend may have an angle of between 20 degrees and 50 degrees in someembodiments. In some embodiments, the bend in the catheter body causes acorresponding bend in the ultrasound transmission member. In this case,sometimes the bend in the catheter body has an angle greater than acorresponding angle of the corresponding bend in the ultrasoundtransmission member. Optionally, the catheter may further include asheath disposed over at least a portion of the distal end of thecatheter body for maintaining the bend in the catheter body. Forexample, the sheath may be disposed over the portion of the distal endduring non-use of the catheter and is removed from the catheter bodybefore use. In some embodiments, the catheter may further include ahydrophilic coating disposed along an outside surface of at least aportion of the catheter body. The hydrophilic coating may be anysuitable coating.

The distal head of the catheter device may have any of a number ofdifferent configurations and features. For example, in some embodimentsthe distal head is not directly affixed to the distal end of thecatheter body. Some embodiments further include at least oneside-opening through a side of the distal head. The side-opening maycomprise, for example, a space for introducing an adhesive to couple thedistal head with a guidewire tube disposed in the lumen of the catheterbody. Optionally, the side-opening may extend around at least a portionof a circumference of the distal head. For example, the side-opening maytake the form of a slot.

Some embodiments of the ultrasound catheter include a guidewire tubehaving a proximal end and a distal end and extending longitudinallythrough at least a portion of the lumen of the catheter body and throughat least a portion of the distal head. The guidewire tube may compriseany suitable material such as, in some embodiments, a polyimidematerial. In some embodiments, the guidewire tube is affixed to thedistal head. Furthermore, the guidewire tube may also be affixed to thecatheter body. The side-opening in the distal head, as just described,may sometimes be used for introducing adhesive to affix the distal headto a guidewire tube. For example, the catheter may include aside-opening in the distal head and a polymer sleeve disposed around aportion of the distal head, the polymer sleeve being coupled with theguidewire tube by adhesive extending through the side-opening.

A guidewire tube of an ultrasound catheter may be an over-the-wire tube,a rapid-exchange tube, a monorail tube or any other suitable guidewiretube. In some embodiments, for example, the proximal end of theguidewire tube exits the catheter body nearer the proximal end of thecatheter body than the distal end of the catheter body. Alternatively,the guidewire tube may exit the catheter body nearer the distal end ofthe catheter body than the proximal end of the catheter body. In stillother embodiments, the proximal end of the guidewire tube exits thecatheter body through the proximal end of the catheter body. The last ofthese embodiments may further include a connector device coupled withthe proximal end of the catheter body and the proximal end of theguidewire tube, wherein the guidewire tube extends through at least aportion the connector device. Such a catheter may further comprise acoupling member, such as a sheath or sleeve, for coupling the connectordevice with the catheter body. In other embodiments, the guidewire tubemay exit the catheter body through a guidewire port positioned along thecatheter body at a location separate from the connector device. Such aguidewire port may sometimes include a flexible extension. In someembodiments, the guidewire tube may include micro-perforations orapertures along all or a portion of its length. The micro-perforationsmay allow, for example, passage of fluid into the guidewire lumen toprovided lubrication to a guidewire.

In some embodiments, the connector device just described includes adistal portion for coupling with the proximal end of the catheter body,the distal portion having a common lumen. The device further includes aproximal ultrasound transmission arm having an ultrasound transmissionlumen in communication with the common lumen and a proximal guidewirearm having a guidewire lumen in communication with the common lumen.Optionally, the connector device may also include a proximal infusionarm having an infusion port in communication with the common lumen. Insome embodiments, the ultrasound transmission arm, the distal portion,and the catheter body are disposed along a common longitudinal axis. Insome embodiments, the guidewire arm branches from the distal portion ofthe connector at less of an angle than the infusion arm branches fromthe distal portion of the connector. Any such embodiments may furtherinclude a coupling member for coupling the distal portion of theconnector device with the catheter body.

In some embodiments of the catheter, the ultrasound transmission membermay transmit ultrasound energy from the separate ultrasound device asboth pulsed energy and continuous energy. Such embodiments mayoptionally include an actuator coupled with the ultrasound generatingdevice for switching between transmission of the pulsed energy andtransmission of the continuous energy to the ultrasound transmissionmember. Any of the above embodiments may be sterilized by exposure to anelectron beam.

In another aspect, an ultrasound catheter for disrupting occlusions inblood vessels comprises: an elongate flexible catheter body having aproximal end, a distal end, at least one lumen extending longitudinallythrough the body; an ultrasound transmission member extendinglongitudinally through the lumen of the catheter body, the ultrasoundtransmission member having a proximal end connectable to a separateultrasound generating device and a distal end disposed adjacent thedistal end of the catheter body; and a distal head coupled with thedistal end of the ultrasound transmission member, the distal headpositioned adjacent the distal end of the catheter body; wherein theultrasound transmission member transmits at least two different types ofultrasound energy from the separate ultrasound generator. In someembodiments, the catheter may further include at least one bend in thecatheter body near the distal end. Optionally, the separate ultrasoundgenerating device may include an actuator for switching betweentransmitting a first type of ultrasound energy to the ultrasoundtransmission member and transmitting at least a second type ofultrasound energy to the ultrasound transmission member. For example,the first type of ultrasound energy may comprise pulsed ultrasoundenergy and the second type of ultrasound energy may comprise continuousultrasound energy.

In another aspect, an ultrasound catheter for disrupting occlusions inblood vessels includes an elongate flexible catheter body having aproximal end, a distal end, an external surface, an internal surface, atleast one lumen, and a hydrophilic coating disposed along at least aportion of the external surface. The catheter also includes anultrasound transmission member extending longitudinally through thelumen of the catheter body, the ultrasound transmission member having aproximal end connectable to a separate ultrasound generating device anda distal end disposed adjacent the distal end of the catheter body.Finally, the catheter includes a distal head coupled with the distal endof the ultrasound transmission member, the distal head positionedadjacent the distal end of the catheter body. In some embodiments, thecatheter further comprises at least one bend in the catheter body.

In another aspect, an ultrasound catheter for disrupting occlusions inblood vessels comprises: an elongate flexible catheter body having aproximal end, a distal end, at least one lumen extending longitudinallythrough the body; an ultrasound transmission member extendinglongitudinally through the lumen of the catheter body, the ultrasoundtransmission member having a proximal end connectable to a separateultrasound generating device and a distal end disposed adjacent thedistal end of the catheter body; and a distal head coupled with thedistal end of the ultrasound transmission member, the distal headpositioned adjacent the distal end of the catheter body, wherein theultrasound catheter is sterilized by exposure to an electron beam. Someembodiments of such catheters may further include a bend in the catheterbody near the distal end.

In another aspect, an improved ultrasound catheter of the typecomprising an elongate flexible catheter body having a proximal end, adistal end, and at least one lumen, an ultrasound transmission memberextending longitudinally through the lumen of the catheter body, and adistal head coupled with a distal end of the ultrasound transmissionmember, includes an improvement comprising at least one bend in thecatheter body nearer the distal end of the catheter body than theproximal end.

In still another aspect, an improved ultrasound catheter of the typecomprising an elongate flexible catheter body having a proximal end, adistal end, and at least one lumen, an ultrasound transmission memberextending longitudinally through the lumen of the catheter body, and adistal head coupled with a distal end of the ultrasound transmissionmember, includes an improvement comprising a hydrophilic coatingdisposed along at least a portion of an external surface of the catheterbody.

In another aspect, an ultrasound system for disrupting occlusions inblood vessels comprises an ultrasound catheter, which includes: anelongate flexible catheter body having a proximal end, a distal end, atleast one lumen, and at least one bend in the catheter body nearer thedistal end than the proximal end; an ultrasound transmission memberextending longitudinally through the lumen of the catheter body, theultrasound transmission member having a proximal end and a distal; and adistal head coupled with the distal end of the ultrasound transmissionmember, the distal head positioned adjacent the distal end of thecatheter body. The ultrasound system also includes a separate ultrasoundgenerating device coupled with the proximal end of the ultrasoundtransmission member.

In some embodiments, the separate ultrasound generating device includesan actuator for switching between transmitting a first type ofultrasound energy to the ultrasound transmission member and transmittingat least a second type of ultrasound energy to the ultrasoundtransmission member. For example, in some embodiments the first type ofultrasound energy comprises pulsed ultrasound energy and the second typeof ultrasound energy comprises continuous ultrasound energy.

In yet another aspect, a method of making an ultrasound catheter fordisrupting occlusions in blood vessels comprises forming a catheter bodyover a mandrel, wherein the mandrel includes at least one bend forforming a corresponding bend in the catheter body; separating thecatheter body from the mandrel. The method then involves inserting anultrasound transmission member into a lumen of the catheter body,wherein inserting the ultrasound transmission member reduces an angle ofthe at least one bend in the catheter body.

Any angles, locations or the like for one or more angle(s) may be used.For example, in one embodiment the method comprises forming the bodyover a mandrel having a bend of between about 20 degrees and about 90degrees. In some embodiments, inserting the ultrasound transmissionmember into the lumen reduces the angle of the bend in the catheter bodyto between 15 degrees and 80 degrees. Sometimes, inserting theultrasound transmission member into the lumen causes the ultrasoundtransmission member to bend at the bend in the catheter body. In someembodiments, for example, the ultrasound transmission member bends at anangle less than the angle of the bend in the catheter body. Optionally,some embodiments of the method for making the catheter further includeplacing a sheath over at least a portion of the catheter body tomaintain the bend in the catheter body. Also optionally, someembodiments further involve directing an electron beam at the ultrasoundcatheter to sterilize the catheter.

In still another aspect, a method of making an ultrasound catheter fordisrupting occlusions in blood vessels comprises placing a catheter bodyover a mandrel, wherein the mandrel includes at least one bend forforming a corresponding bend in the catheter body, heating the catheterbody, removing the catheter body from the mandrel, and inserting anultrasound transmission member into a lumen of the catheter body,wherein inserting the ultrasound transmission member reduces an angle ofthe at least one bend in the catheter body.

In another aspect, a method for disrupting an occlusion in a bloodvessel comprises positioning an ultrasound catheter in the blood vesselsuch that a distal end of the catheter is adjacent the occlusion,transmitting a first type of ultrasound energy to an ultrasoundtransmission member of the ultrasound catheter to disrupt the occlusion,and transmitting a second type of ultrasound energy to the ultrasoundtransmission member to further disrupt the occlusion. In someembodiments of the method, the first type of ultrasound energy comprisespulsed energy and the second type of energy comprises continuous energy.In other embodiments, the first type of ultrasound energy comprisescontinuous energy and the second type of energy comprises pulsed energy.The method may further comprise switching from transmitting the secondtype of ultrasound energy to transmitting the first type of ultrasoundenergy. Any of these methods may also include repeating at least one ofthe transmitting and switching steps at least once.

In some cases, transmitting the first type of energy and transmittingthe second type of energy involves activating an actuator on a separateultrasound generating device coupled with the ultrasound catheter. Insome embodiments, positioning the catheter comprises using a bend in theultrasound catheter to advance the catheter into a position adjacent theocclusion. The method may further comprise using a bend in the catheterto reposition the ultrasound catheter in an additional blood vesseladjacent an additional occlusion and transmitting at least one form ofultrasound energy to the ultrasound transmission member to disrupt theadditional occlusion.

In any of the above methods, positioning the device may involveadvancing the ultrasound catheter over a guidewire. Such advancing ofthe ultrasound catheter over the guidewire may involve advancing over aguidewire disposed in a guidewire lumen of the catheter, the guidewirelumen extending at least a majority of a length of the catheter.Optionally, the guidewire lumen may extend the full length of thecatheter and may be coupled with a connector device coupled with aproximal end of the ultrasound catheter. In some embodiments, the methodmay further involve injecting dye into the blood vessel through theguidewire lumen. Alternatively, dye may be injected through a cathetervia means other than a guidewire lumen.

BRIEF DESCRIPTION OF THE DRAWING FIGURES

FIG. 1 a is a side view of a mandrel and a catheter body, showing amethod for making a catheter body according to an embodiment of thepresent invention;

FIG. 1 b is a cross-sectional side view of a distal end of a catheterbody and an ultrasound transmission member within the body according toan embodiment of the present invention;

FIG. 2 is a cross-sectional side view of a distal end of an ultrasoundcatheter device according to an embodiment of the present invention;

FIG. 2 a is a cross-sectional front view of an ultrasound catheterdevice from the perspective of the arrows labeled “a” in FIG. 2;

FIG. 2 b is a partial cut-away perspective view of an ultrasoundtransmission member with a friction reducing coating or jacket accordingto an embodiment of the present invention;

FIG. 3 is a cross-sectional view of a distal end of an ultrasoundcatheter device according to another embodiment of the presentinvention;

FIG. 4 is a cross-sectional view of a distal end of an ultrasoundcatheter device according to another embodiment of the presentinvention;

FIG. 5 is a cross-sectional view of a distal end of an ultrasoundcatheter device according to another embodiment of the presentinvention;

FIG. 5 a is an exploded, cross-sectional, side view of a distal head,ultrasound transmission member and guidewire tube of an ultrasoundcatheter device according to an embodiment of the invention;

FIG. 6 is a cross-sectional view of a distal end of an ultrasoundcatheter device according to another embodiment of the presentinvention;

FIG. 7 is a cross-sectional view of a proximal connection assembly of anultrasound catheter device according to an embodiment of the presentinvention;

FIG. 7 a is an exploded side view of a proximal connection assembly asin FIG. 7;

FIG. 8 is a side view of a proximal end of an ultrasound catheter devicecoupled with a connector device according to an embodiment of thepresent invention; and

FIG. 8 a is an exploded, side view of a proximal end of an ultrasoundcatheter device and a connector device according to an embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

Ultrasound catheter devices and methods of the present invention maygenerally be used for treating occlusions in blood vessels. Catheterdevices generally include a catheter body, an ultrasound energytransmission member disposed within the catheter body and a distal headcoupled with the energy transmission member and disposed at or near thedistal end of the catheter body. The ultrasound transmission membertransmits ultrasound energy from an ultrasound transducer to the distalhead, causing the head to vibrate and, thus, disrupt vascularocclusions.

Some embodiments of an ultrasound catheter include at least one bend inthe catheter body for enhancing positioning and/or advancement of thecatheter in a blood vessel. A bend may facilitate, for example,placement or repositioning of the catheter in a branching vessel thatbranches off of a larger vessel. The bend in the catheter body istypically formed by heating the body while it is on a mandrel, but othersuitable methods may be employed. The bend is formed when before theultrasound transmission member is inserted into the catheter body, so asto reduce stress on the transmission member. In some embodiments, thetransmission member bends somewhat when it is placed in the catheterbody, but to a lesser degree than the catheter body is bent. Variouslocations for one or more bends n the catheter body, various angles forthe bend(s) and the like may be used in various embodiments of theultrasound catheter, as desired.

Other embodiments of an ultrasound catheter may include various otherimprovements. For example, some embodiments include a sheath formaintaining a bend in the catheter when not in use. Some embodimentsinclude a hydrophilic coating disposed over at least a portion of theexternal surface of the catheter body to enhance the lubricity of thebody and facilitate advancement of the catheter through a blood vessel.Some embodiments include an over-the-wire guidewire tube to allow forenhanced injection of dye or other fluids near an occlusion and/or tofacilitate guidewire changing during a procedure. Some embodimentsinclude a distal head with an opening configured for enhanced attachmentof the head to a guidewire tube disposed within the catheter body. Insome embodiments, an ultrasound transducer coupled with the ultrasoundcatheter may be switched, via an actuator, between a pulsed ultrasoundenergy mode, a continuous ultrasound energy mode and/or other ultrasoundenergy modes, as desired. Some embodiments are sterilized viaelectron-beam sterilization. In any given embodiment, an ultrasoundcatheter may include any suitable combination of the features describedabove, as well as any other suitable features. These features will bedescribed in further detail below in the form of examples, but theseexamples should in no way be interpreted to limit the scope of theinvention as it is defined in the claims.

Referring now to FIG. 1, one embodiment of an ultrasound catheter system20 suitably includes an ultrasound catheter 10, a proximal end connectorassembly 12 coupled with catheter 10, an ultrasound transducer 14coupled with the proximal end of a proximal connector assembly 12, andan ultrasound generator 16 with a power cord 17 and foot-actuated on/offswitch 18, which is operatively coupled with ultrasound transducer 14 toprovide ultrasonic energy to transducer 14 and, thus, to ultrasoundcatheter 10. Generally, catheter 10 includes an ultrasound transmissionmember, or wire (not shown), for transmitting energy from the transducer14 to a distal head 26 of the catheter. In some embodiments, catheter 10includes one or more bends 117 along its length for facilitatingpositioning and/or advancement of catheter 10. Components of system 20may be coupled via any suitable means, such as connecting wires 11 a, 11b of any kind, wireless connections or the like.

Proximal connector assembly 12, described more fully below, may have aconnector device 15, such as the W-connector that is shown, aY-connector or the like. Connector device 15 may include any suitablenumber of side-arms or ports, such as a guidewire arm 19 for passage ofa guidewire and an infusion arm 13 for infusing and/or withdrawingirrigation fluid, dye and/or the like. In other embodiments, catheter 10may be passed along a guidewire which accesses catheter 10 via a sideaperture rather than connector device 15. For example, some embodimentsinclude a rapid exchange guidewire lumen. Ultrasound catheters 10 of thepresent invention may be used with any suitable proximal devices, suchas any suitable ultrasound transducer 14, ultrasound generator 16,connector assembly 12, connector device(s) 15 and/or the like.Therefore, exemplary FIG. 1 and any following descriptions of proximalapparatus or systems for use with ultrasound catheters 10 should not beinterpreted to limit the scope of the present invention as defined inthe appended claims.

In some embodiments, ultrasound generator 16, ultrasound transducer 14or any other suitable component of system 20 may include one or moreactuators 119 for switching between two or more modes or types ofultrasound energy transmission to an ultrasound transmission member ofcatheter 10. Actuator 119 may be used, for example, to switch betweentransmission of pulsed ultrasound signal and continuous ultrasoundsignal. Providing two or more different types of ultrasound signal mayenhance disruption of a vascular occlusion, and in various embodiments,switching between types of signals may be performed in any orderdesired, as many times as desired, without stopping the transmission ofultrasound energy to make the switch and/or the like. Although actuator119 is pictured on ultrasound generator 16 in FIG. 1, it may be givenany other location and configuration.

Referring now to FIG. 2, a cross-sectional side view of the distal endof one embodiment of ultrasound catheter 10 is shown. Generally,ultrasound catheter 10 suitably includes an elongate catheter body 22with at least one hollow catheter body lumen 21. In FIG. 2, catheterbody 22 is shown having one lumen, but it may have any number of lumensin various embodiments. Disposed longitudinally within catheter bodylumen 21 are an ultrasound transmission member 24 and a hollow guidewiretube 28 forming a guidewire lumen 29. Coupled with the distal ends ofultrasound transmission member 24 and guidewire tube 28 is a distal head26, positioned adjacent the distal end of catheter body 22.

Generally, the various coupled components described above may be coupledby any suitable means, such as adhesives, complementary threadedmembers, pressure fittings, and the like. For example, distal head 26may be coupled with ultrasound transmission member 24 and guidewire tube28 with any suitable adhesive substance. In one embodiment, for example,guidewire tube 28 is coupled with distal head 26 by means of adhesive atmultiple head/guide wire adhesive points 30. In some embodiments,guidewire tube 28 may also be coupled with catheter body 22 by adhesiveor other means at one or more body/guidewire adhesive points 32. Asexplained further below, some embodiments of distal head 26 include oneor more apertures for facilitating introduction of adhesive to coupledistal head 26 to guidewire tube 28.

Catheter body 22 is generally a flexible, tubular, elongate member,having any suitable diameter and length for reaching a vascularocclusion for treatment. In one embodiment, for example, catheter body22 preferably has an outer diameter of between about 0.5 mm and about5.0 mm. In other embodiments, as in catheters intended for use inrelatively small vessels, catheter body 22 may have an outer diameter ofbetween about 0.25 mm and about 2.5 mm. Catheter body 22 may also haveany suitable length. Some ultrasound catheters, for example, have alength in the range of about 150 cm. However, any other suitable lengthmay be used without departing from the scope of the present invention.Examples of catheter bodies similar to those which may be used in thepresent invention are described in U.S. Pat. Nos. 5,267,954 and5,989,208, which were previously incorporated herein by reference.

As mentioned above, and with reference again to FIG. 1, in someembodiments of ultrasound catheter 10 catheter body 22 includes one ormore bends 117 along its length, for enhancing advancing and/orpositioning catheter 10. For example, bend 117 may facilitateadvancement of catheter 10 into a side-branch vessel of a larger vessel.Bend 117 may be located at any suitable location along catheter 10 andmay have any suitable angle, relative to the longitudinal axis ofcatheter 10, and any number of bends 117 having any number ofconfigurations are contemplated within the scope of the invention. Insome embodiments, for example, catheter body 22 includes one bend,located between about 1 mm and about 20 mm from the distal end ofcatheter body 22, and preferably between about 5 mm and about 15 mm fromthe distal end of catheter body 22, and even more preferably betweenabout 7 mm and about 10 mm from the distal end of catheter body 22.

Generally, and with reference now to FIG. 1 a, in one embodiment of amethod for making catheter 10, bend 117 in catheter body 22 is formed bypositioning catheter body 22 on a mandrel 114. In some embodiments,catheter body 22 is formed on mandrel 114, while in other embodimentscatheter body 22 may be pre-formed and then placed on mandrel 114 forforming bend 117. In either case, mandrel 114 may include or be coupledwith a stopper member 120. Stopper member 120 generally maintains aposition of catheter body 22 on mandrel 114, to help ensure theformation of bend 117 in a desired location. In some embodiments,catheter body 22 or material for making catheter body 22 is placed onmandrel 114 and is advanced until one end 118 of the material is stoppedby stopper 120. In some embodiments, catheter body 22 is then heated inorder to form bend 117. After bend 117 is formed, catheter body 22 maybe separated from mandrel 114 and used as part of catheter 10. This isbut one example of a method for making catheter body 22, and anysuitable alternative methods including a mandrel for making a bend arecontemplated within the scope of the invention.

As previously mentioned, bend 117 may have any suitable angle ofdeflection, relative to the longitudinal axis of catheter 10. In someembodiments, for example, bend 117 may have an angle of between about 20degrees and about 50 degrees, and preferably an angle of between about30 degrees and about 40 degrees. In some embodiments, catheter body 22may be formed having an angle that is greater, or more severe, than thefinal angle of bend 117 of catheter 10. In other words, when anultrasound transmission member is inserted into a bent catheter body 22,the ultrasound transmission member will typically bend slightly toconform to bend 117, and catheter body 22 will straighten slightly toconform to the ultrasound transmission member. Thus, catheter body 22 insome embodiments will be formed having bend 117 with an angle that islarger than the final angle that bend 117 will have when the ultrasoundtransmission member is inserted. In FIG. 1 a, for example, bend 117 hasan angle of approximately 90 degrees. Other embodiments may use anyother suitable angles for bend 117 of catheter body 22 to arrive at adesired angle for bend 117 when the ultrasound transmission member isinserted. For example, mandrels may have bends with angles of betweenabout 20 degrees and about 90 degrees, or any other suitable angle, andmay result in a catheter body having a bend of between about 15 degreesand about 80 degrees when an ultrasound transmission wire is inserted,or any other suitable angle.

As just discussed, in one aspect of the invention, and with referencenow to FIG. 1 b, bend 117 in catheter body 22 has a more acute anglethan a corresponding bend in ultrasound transmission member 24 insertedin catheter body 22. This generally occurs because catheter body 22straightens somewhat when ultrasound transmission member 24 is insertedand ultrasound transmission member 24 bends somewhat to conform to bend117 in catheter body 22. In some embodiments, as shown, ultrasoundtransmission member 24 is at least partially free to move within thelumen of catheter body 22 so that it remains as straight as possible andis not forced to bend to the same extent that catheter body 22 is bent.This less-bent configuration places less of a strain on ultrasoundtransmission member 24 during use, which in turn results in less wearand tear of ultrasound transmission member 24 and a longer life of thedevice than would occur if ultrasound transmission member 24 were moreseverely bent.

Because ultrasound transmission member 24 may tend to straighten bend117 to a degree, some embodiments of catheter 10 include a sheath,sleeve, cover or other shape-retention device for placement over atleast a portion of catheter body 22 when catheter 10 is not in use. Forexample, a shape-retention device may comprise a short, rigid, plasticsheath, having a bend in its length. When placed over catheter body 22at bend 117, the sheath may help retain the shape and angle of bend 117during non-use. When catheter 10 is to be used, the sheath is removed.Any suitable size, shape or material may be used for making such ashape-retention device and any such device falls within the scope of thepresent invention.

In some embodiments, catheter 10 includes a coating on the external oroutward-facing surface of catheter body 22. Coatings may alternativelybe applied to any other surface or combination of surfaces of catheter10, as desired. A coating may be made of any suitable material, may haveany suitable thickness and may cover any suitable length of catheterbody 22. In some embodiments, for example, the coating is made from oneor more hydrophilic materials, which provide increased lubricity anddecreased friction for the external surface of catheter body 22, thusenhancing advancement and/or positioning of catheter 10 in a bloodvessel. For example, a hydrophilic coating on catheter body 22 may besimilar to the coatings described in U.S. Pat. No. 5,538,512, entitled“Lubricious Flow Directed Catheter,” the full disclosure of which ishereby incorporated by reference. As described in U.S. Pat. No.5,538,512, materials used for coatings may include, but are not limitedto, polymers or oligomers of monomers selected from ethylene oxide andits higher homologs, including up to 6 carbon atoms; 2-vinyl pyridine;N-vinylpyrrolidone; polyethylene glycol acrylates such as mono-alkoxypolyethylene glycol mono(meth)acrylates, including mono-methoxytriethylene glycol mono(meth)acrylate, mono-methoxy tetraethylene glycolmono(meth)acrylate, polyethylene glycol mono(meth)acrylate; otherhydrophilic acrylates such as 2-hydroxyethylmethacrylate,glycerylmethacrylate; acrylic acid and its salts; acrylamide andacrylonitrile; acrylamidomethylpropane sulfonic acid and its salts,cellulose, cellulose derivatives such as methyl cellulose ethylcellulose, carboxymethyl cellulose, cyanoethyl cellulose, celluloseacetate, polysaccharides such as amylose, pectin, amylopectin, alginicacid, and cross-linked heparin; maleic anhydride; aldehydes; etc. Thesemonomers may be formed into homopolymers or block or random copolymers.The use of oligomers of these monomers in coating the catheter forfurther polymerization is also an alternative. Preferred monomersinclude ethylene oxide; 2-vinyl pyridine; N-vinylpyrrolidone and acrylicacid and its salts; acrylamide and acrylonitrile each polymerized (withor without substantial crosslinking) into homopolymers, or into randomor block copolymers.

Additionally, hydrophobic monomers may be included in the polymericcoating material in an amount up to about 30% by weight of the resultingcopolymer, so long as the hydrophilic nature of the resulting copolymeris not substantially compromised. Suitable monomers include ethylene,propylene, styrene, styrene derivatives, alkylmethacrylates,vinylchloride, vinylidenechloride, methacrylonitrile, and vinyl acetate.Preferred, because of their propensity for ease of linkage to thetypical polymeric catheter substrates, are ethylene, propylene, styrene,and styrene derivatives.

For further details regarding materials for coatings, methods forpreparing and/or applying coatings, and/or the like, reference may bemade to U.S. Pat. No. 5,538,512. Alternatively, any other suitablehydrophilic coating may be applied to an exterior surface and/or anyother surface of catheter 10, without departing from the scope of thepresent invention.

Returning to FIG. 2, in many embodiments, ultrasound transmission member24 extends longitudinally through catheter body lumen 21 to transmitultrasonic energy from ultrasound transducer 14, connected to theproximal end of catheter 10, to the distal end of catheter 10.Ultrasound transmission member 24 may be formed of any material capableof effectively transmitting ultrasonic energy from ultrasound transducer14 to the distal end of catheter body 22, including but not limited tometals such as titanium and nickel alloys.

In accordance with one aspect of the invention, all or a portion ofultrasound transmission member 24 may be formed of one or more materialswhich exhibit superelastic properties. Such material(s) shouldpreferably exhibit superelasticity consistently within the range oftemperatures normally encountered by ultrasound transmission member 24during operation of ultrasound catheter apparatus 10. Specifically, allor part of the ultrasound transmission member 24 may be formed of one ormore metal alloys known as “shape memory alloys.”

Use of supereleastic metal alloys in ultrasound transmission members isdescribed in U.S. Pat. No. 5,267,954, previously incorporated byreference. Examples of superelastic metal alloys which may be used aredescribed in detail in U.S. Pat. No. 4,665,906 (Jervis); U.S. Pat. No.4,565,589 (Harrison); U.S. Pat. No. 4,505,767 (Quin); and U.S. Pat. No.4,337,090 (Harrison), the entire disclosures of which are herebyincorporated by reference insofar as they describe the compositions,properties, chemistries and behavior of specific metal alloys which aresuperelastic within the temperature range at which ultrasoundtransmission member 24 of the present invention operates, any and all ofwhich superelastic metal alloys may be used to form ultrasoundtransmission member 24 of the present invention.

In many embodiments, ultrasound transmission member 24 includes one ormore tapered regions along a portion of its length, towards its distalend. Such a tapered region 23 decreases the distal rigidity ofultrasound transmission member 24, thus amplifying ultrasound energytransmitted along ultrasound transmission member 24 to distal head 26.Tapered region 23 typically divides the transmission member 24 between aproximal portion and a distal portion, which both typically have alarger cross-sectional diameter than tapered region 23, as pictured inFIG. 2. A thicker distal portion, for example, may enhance stability ofthe connection between ultrasound transmission member 24 and distal head26. Other embodiments are contemplated, however. For example, taperedregion 23 may be positioned at the extreme distal end of transmissionmember 24. In still other embodiments, ultrasound transmission member 24may include multiple tapered portions, widened portions and/or the like.Thus, ultrasound transmission member 24 may be configured with anysuitable length, combinations of diameters and tapers, or any othersuitable shapes, sizes or configurations to advantageously transmitultrasound energy from transducer 14 to distal tip 26.

With reference now to FIG. 2 b, in some embodiments ultrasoundtransmission member 24 may include a low-friction coating 25, jacket orsimilar covering on all or a portion of its outer surface. Coating 25may be disposed on the outer surface of ultrasound transmission member24 so as to completely cover ultrasound transmission member 24 along itsentire length, or along a discrete region or regions thereof. Suchcoating or jacket 25 may comprise a layer of low friction polymermaterial such as polytetrafluoroethylene (PTFE), TEFLON™ (available fromDupont, Inc., Wilmington, Del.) or other plastic materials such aspolyethylene. Coating 25 may be applied as a liquid and subsequentlyallowed to cure or harden on the surface of ultrasound transmissionmember 24. Alternatively, coating 25 may be in the form of an elongatetube, disposable over the outer surface of ultrasound transmissionmember 24. Generally, coating 25 serves to prevent or diminish frictionbetween the outer surface of ultrasound transmission member 24 and theadjacent structures of catheter 10 or proximal end connector assembly 12through which ultrasound transmission member 24 extends.

In most embodiments, distal head 26 is mounted on or otherwise coupledwith the distal end of ultrasound transmission member 24. In manyembodiments, as shown in FIG. 2, distal tip includes a proximal region27 with an outer diameter configured to fit within the distal end ofcatheter body lumen 21 and a distal region 29 with a slightly largerdiameter than proximal region 27. In many embodiments, all or a portionof distal region 29 of distal head 26 will have an outer diameterapproximately the same as the outer diameter of catheter body 22. Thus,in embodiments like the one pictured in FIG. 2, the distal end ofcatheter body 22 overlaps at least a portion of distal head 26. Theamount of overlap may vary in different embodiments, so that in someembodiments catheter body 22 may completely overlap distal head 26. Thisoverlapping may enhance stability of the distal end of catheter 10 anddistal head 26 in particular.

In another embodiment, as shown in FIG. 3, distal head 34 is configuredso that its proximal end abuts the distal end of catheter body 22. Inthis embodiment, distal head 26 is held in position adjacent catheterbody 22 by its attachment to ultrasound transmission member 24 and/orguide wire tube 28 and does not fit within catheter body lumen 21.Typically, in such an embodiment, all or a portion of distal head 34will have an outer diameter that is approximately equal in dimension tothe outer diameter of catheter body 22.

As is evident from distal heads 26 and 34, shown in FIGS. 2 and 3,distal heads may have any suitable configuration, shape, and sizesuitable for ablating or otherwise disrupting occlusions. For example,distal head 26, 34 may have a shape that is bulbous, conical,cylindrical, circular, rectangular or the like. Similarly, distal head26, 34 may have dimensions which allow it to fit wholly or partiallywithin the distal end of catheter body lumen 21 or may, alternatively,be disposed completely outside catheter body lumen 21. Thus, theconfiguration of distal head 26 may take any suitable form and should inno way be limited by the exemplary embodiments pictured in FIGS. 2 and 3and described above or below.

In some embodiments, distal head 26 is not directly affixed to thedistal end of catheter body 22. Instead, in various embodiments, it isheld in place by its attachment to either ultrasound transmission member24, guidewire tube 28, or both. In some embodiments, distal head 26 mayadditionally be secured to the distal end of catheter body 22 by fittingpartially or wholly within catheter body lumen 21, as described above.In embodiments where distal head 26 is not directly affixed to thedistal end of catheter body, distal head 26 will be able to move freely,relative to the distal end of catheter body 22. Positioning distal head26 in this way, without affixing it to catheter body 22, allows greaterfreedom of movement of head 26, providing enhanced efficiency ofultrasound energy transmission and reduced stress to ultrasoundtransmission member 24.

Distal head 26 may be coupled indirectly with catheter body 22 at one ormore points proximal to the distal end of catheter body 22. In someembodiments, for example, distal head 26 is indirectly coupled to thecatheter body 22 via guidewire tube 28, as described further below. Forexample, distal head 26 may be coupled with guidewire tube 28, andguidewire tube 28 may be coupled with catheter body 22 at a locationwithin 1 cm of the distal end of catheter body 22, at a location around25 cm from the distal end of catheter body 22, or at any other locationor combination of locations. In other embodiments, distal head 26 may becoupled with ultrasound transmission member 24, and ultrasoundtransmission member 24 may be coupled with catheter body 22 near itsproximal end and/or at any other suitable location.

In some embodiments, distal head 26 is formed of radiodense material soas to be easily discernable by radiographic means. For example, distalhead 26 may be formed of a metal or metal alloy. Alternatively, distalhead 26 may be made of a polymer or ceramic material having one or moreradiodense markers affixed to or located within distal head 26. In oneembodiment, for example, distal head 26 may be molded of plastic such asacrylonitrile-butadiene-styrene (ABS) and one or more metallic foilstrips or other radiopaque markers may be affixed to such plastic distalhead 26 in order to impart sufficient radiodensity to permit distal head26 to be readily located by radiographic means. Additionally, inembodiments wherein distal tip 26 is formed of molded plastic or othernon-metallic material, a quantity of radiodense filler such as powderedbismuth or BaSO₄ may be disposed within the plastic or othernon-metallic material of which distal head 26 is formed so as to impartenhanced radiodensity to distal head 26.

In some embodiments, guidewire tube 28 is also disposed longitudinallywithin catheter body lumen 21, along all or a portion of the luminallength. Guidewire tube 28 may also extend through distal head 26, asshown in FIGS. 2 and 3, to allow a guidewire to pass through the distalend of distal head 26. Alternatively, guidewire tube 28 and guidewirelumen 29 may be given any suitable configuration, length, diameter andthe like suitable for passing catheter 10 along a guide wire to alocation for treatment. For example, in some embodiments, a relativelyshort guidewire lumen 29 may be formed near the distal end of catheterbody 22 to permit rapid exchange of catheters. In other embodiments,catheter 10 may include an over-the-wire guidewire tube 28 and guidewirelumen 29 that extend along all or almost all of the length of catheter10. Such an over-the-wire configuration may be beneficial for providingmeans for a super-selective dye injection at a location near anocclusion, for facilitating one or more changes of guidewires during aprocedure, for enhancing manipulation of catheter 10 and/or the like. Insome embodiments, guidewire tube 28 may include micro-perforations orapertures along all or a portion of its length. The micro-perforationsmay allow, for example, passage of fluid into the guidewire lumen toprovided lubrication to a guidewire. In some embodiments havingover-the-wire guidewire tubes 28, guidewire lumens 29 may be accessedvia a guidewire arm 19 on connector device 15. Again, connector device15 may comprise a W-connector, a Y-connector or any other suitabledevice. Thus, catheters 10 of the present invention are not limited tothose including guidewire tubes 28 and or guidewire lumens 29 asdescribed by FIGS. 2 and 3, but may include any suitable guidewirelumens, tubes or the like.

In some embodiments, guidewire tube 28 is attached to both distal head26 and catheter body 22. As previously described, such attachment may beaccomplished by any suitable means, such as by an adhesive substance.Generally, guidewire tube 28 is attached within a portion of distal head26 at one or more adhesive points 30. An outer wall of guidewire tube 28also may be attached to an inner wall of catheter body 22 at one or moreguidewire tube/catheter body adhesive points 32. For example, in someembodiments tube/catheter body adhesive point 32 is locatedapproximately 25 cm from the distal end of catheter body 22. Otherembodiments may include one tube/catheter body adhesive point atapproximately 25 cm from the distal end of catheter body 22 and anothertube/catheter body adhesive point within approximately 1 cm of thedistal end of catheter body 22. Any suitable adhesive point orcombination of multiple adhesive points is contemplated.

Such attachment of guidewire tube 28 to both distal head 26 and catheterbody 22 helps to hold distal head 26 in its position at the distal endof catheter body 22. Attachment also helps limit unwanted transversemotion of distal head 26 while allowing longitudinal motion due to tubeelasticity. Adhesives used to attach guide wire tube 28 to distal head26 and catheter body 22 may include, but are not limited tocyanoacrylate (eg. Loctite™, Loctite Corp., Ontario, CANADA or DronAlpha™, Borden, Inc., Columbus, Ohio) or polyurethane (e.g. Dymax™,Dymax Engineering Adhesive, Torrington, Conn.) adhesives.

In still other embodiments, a portion of distal head 26 may be formed toextend laterally wider than the outer surface of catheter body 22 andguidewire tube 28 may be positioned on the outer surface of catheterbody 22. Such embodiments, wherein guidewire tube 28 is positioned alongthe outer surface of catheter body 22, are commonly referred to as“monorail” catheters, as opposed to “over-the-wire” catheters asdescribed by FIGS. 2 and 3. In addition to over-the-wire embodiments andmonorail embodiments, ultrasound catheter 10 may also be configured as acombination or hybrid of over-the-wire and monorail embodiments.Specifically, such embodiments may include an ultrasound catheter 10having a guidewire tube 28 formed through a distal portion of catheterbody 22 only, with a guidewire entry/re-entry aperture being formedthrough a sidewall of catheter body 22 to permit passage of a guidewirefrom the distal guidewire lumen of the catheter to a position outsidethe catheter body.

With reference now to FIG. 2 a, some embodiments of ultrasound catheter10 include one or more fluid outflow apertures 36 in distal head 26 topermit fluid flow out of catheter body lumen 21. Other embodiments (notshown) may include one or more similar apertures at or near the distalend of catheter body 22, either in addition to or in place of apertures36 in distal head 26. Outflow apertures 36 facilitate continual orintermittent passage of irrigant liquid through lumen 21, for example byinfusion into lumen 21 via one or more side-arms 11, 13. Infusion ofirrigant liquid through lumen 21, in proximity to ultrasoundtransmission member 24, may be used to control the temperature ofultrasound transmission member 24 to prevent overheating during use andenhance the process of disruption of blood vessel obstruction. Irrigantliquids may include, but are not limited to, saline and the like.

In some embodiments, guidewire tube 28 and lumen 29 are generallyconfigured with an inner diameter slightly larger than the outerdiameter of a guide wire along which catheter 10 is passed. Such aguidewire tube 28 may then be used as an alternative or additional meansto allow fluid outflow through distal head 26. In still otherembodiments, one or more separate lumens having separate outflowapertures formed at or near the distal tip of the catheter may be formedfor infusion of oxygenated perfusate, medicaments or other fluids intothe blood vessel or other anatomical structure in which the catheter ispositioned.

Referring now to FIG. 4, some embodiments of ultrasound catheter 10include a distal sleeve 72 which is coupled with catheter body 22 andwhich surrounds a portion of ultrasound transmission member 24.Generally, distal sleeve 72 comprises a hollow cylindrical member, madeof any suitable material, such as but not limited to a polymer. Sleeve72 is coupled with catheter body 22 within lumen 21 at a location nearthe distal end of catheter body 22. Sleeve 72 may be coupled with body22 via any reasonable means but will often by coupled via an adhesive atone or more adhesive points 74, such as those described above forcoupling other components of catheter 10.

By surrounding a portion of ultrasound transmission member 24 and beingcoupled with catheter body 22, distal sleeve 72 adds stability tocatheter 10. Although it is not necessary for use of catheter 10 anddoes not enhance the performance of catheter 10, physicians often twistor torque catheters radially upon insertion and/or during use of acatheter. Such twisting motions may cause guidewire tube 28 to kinkand/or collapse as tube 28 moves in relation to catheter body 22 andtransmission member 24. Placement of distal sleeve 72 aroundtransmission member 24 causes the components of catheter 10 to movetogether when catheter 10 is twisted, thus avoiding kinking orcollapsing of guidewire tube 28 and maintaining patency of guide wirelumen 29.

Referring now to FIG. 5, another embodiment of ultrasound catheter 10includes a distal head sheath 82. Distal head sheath 82 is generally acylindrical sheath that surrounds a portion of distal head 26. Sheath 82is coupled with guidewire tube 28 via an adhesive at an adhesive point84, which is accessed through a small hole 86 in a side portion ofdistal head 26. Sheath 82 may be made of any suitable material, but willtypically be made of a polymer of the same or similar material withwhich guidewire tube 28 is made. Securing sheath 82 to tube 28 throughhole 86 in distal head 26, enhances the stability of the connectionbetween tube 28 and distal head 26. Thus, there is less chance thatdistal head 26 will break off from catheter 10 and safety of the deviceis enhanced. Forming sheath 82 and guidewire tube 28 from the same orsimilar materials will allow for a secure connection between the two viaan adhesive.

With reference to FIG. 5 a, an exploded side view of distal head 26,ultrasound transmission member 24 and guidewire tube 28 is shown. Insome embodiments, distal head 26 may include an opening 130, forfacilitating the introduction of an adhesive. Opening 130 is typicallylarger than hole 86, described above, but may have any suitableconfiguration. In some embodiments, for example, opening 130 comprises aslot or similarly configured opening disposed around at least a portionof the circumference of distal head 26. Any other suitable configurationis contemplated within the scope of the invention, but opening 130 isgenerally configured to facilitate access through a portion of distalhead 26 to allow introduction of one or more adhesive substances. Suchadhesives, for example, may directly couple distal head 26 to guidewiretube 28, may couple sheath 82 (not shown in FIG. 5 a) to guidewire tube28 and/or the like. Enhanced adhesive coupling via opening 130 mayenhance the useful life of catheter 10 by preventing detachment ofdistal head 28 from guidewire tube 28 or some other part of catheter 10.

With reference now to FIG. 6, yet another embodiment of catheter 10includes a distal head anchor 94. Distal head anchor 94 may comprise awire or similar device made from metal, polymer or any other suitablematerial. Generally, a distal portion of anchor 94 is coupled withdistal head 26 at an adhesive point 96, and a proximal portion of anchor94 is coupled with catheter body 22 at an adhesive point 92 proximal tothe extreme distal end of catheter body 22. Therefore, distal head 26remains free-floating relative to the extreme distal end of catheterbody 22 but is anchored to catheter body 22 at a more proximal location92. This anchoring helps ensure that distal head 26 will not break offfrom catheter 10 during use. Any suitable anchoring device may be usedand is contemplated within the scope of the invention.

Various types and designs of proximal end connector apparatus 12,ultrasound transducers 14, ultrasound generation devices 16 and/or thelike may be coupled with ultrasound catheter 10 for use of catheter 10to disrupt vascular occlusions. Detailed descriptions of such apparatusmay be found, for example, in U.S. Pat. Nos. 5,267,954 and 5,380,274,invented by the inventor of the present invention and previouslyincorporated herein by reference. Therefore, the ultrasound cathetersapparatus 20 and methods are not limited to use with any particulartransducers 14, ultrasound generators 16, connector apparatus 12 or thelike.

That being said, and with reference now to FIG. 7, one embodiment ofproximal end connector apparatus 12 suitably includes a housing 42 witha hollow inner bore 44. Bore 44 may have a uniform inner diameter alongits length or, alternatively, may have multiple segments, such as aproximal segment 47, a middle segment 45 and a distal segment 49, eachof which may surround one or more various components of proximal endconnector apparatus 12.

Generally, proximal segment 47 of bore 44 is configured to allowattachment to ultrasound transducer 56, via transducer housing 58 andtransducer thread 54. As such, proximal segment 47 includes a proximalportion of sonic connector 48, including a sonic connector thread 52 forconnection with complementary transducer thread 54. Proximal segment 47and/or the proximal end 41 of housing 42 may have any shape, diameter orconfiguration to allow coupling with transducer housing 58. As shown inFIG. 7, proximal segment 47 may have an inner diameter of a size toallow transducer housing 58 to fit within it. Thus, transducer housing58 and proximal end 41 may be coupled via a pressure fit. In otherembodiments, transducer housing 58 and proximal end 41 may connect viacomplementary threads. In still other embodiments, transducer housing 58may fit around the outer diameter of proximal end 41. It should beapparent that any suitable configuration of proximal end may be used.

Similarly, sonic connector thread 52 may have any suitable size, shapeand configuration for coupling with a complementary transducer thread54. Such coupling may be achieved via complementary threads, snap-fitmechanism, or any other suitable means. Otherwise, sonic connectorthread 52 and sonic connector 48 are generally configured to transmitultrasound energy from ultrasound transducer 56 to ultrasoundtransmission member 24. A pin 50 is generally positioned within sonicconnector 48 and is disposed between proximal segment 47 and middlesegment 45 of bore 44.

Middle segment 45 of bore 44 typically surrounds a portion of sonicconnector 48, which is coupled with the distal end of ultrasoundtransmission member 24, and one or more sets of absorber members 46,which surround a portion of ultrasound transmission member 24 to reducevibration of member 24. Absorber members 46 may include, for example,one or more O-rings. Sonic connector 48 is coupled with the distal endof ultrasound transmission member 24 by any suitable means, to transmitultrasound energy to member 24 from transducer 56.

Absorber members 46 are configured to circumferentially surroundultrasound transmission member 24 in whole or in part to dampentransverse vibrations created by the transmission of ultrasound energy.The number, size and configuration of absorber members 46 used may bedetermined based upon a desired level of dampening and any suitableconfiguration or combination may be used. Alternatively, other dampeningstructures may be used, rather than absorber members 46, and thus theconfiguration of proximal connector apparatus 12 is not limited to theuse of one or more sets of absorber members 46.

Distal segment 49 of bore 44 typically surrounds a portion of ultrasoundtransmission member 24 and may also contain one or more additional setsof absorber members 46. Distal segment 49 may also contain a portion ofconnector device 15, which is coupled with the distal end 43 of housing42 of proximal end connector apparatus 12. Again, connector device 15may comprise a Y-connector as in FIGS. 7 and 7 a, a W-connector as inFIGS. 8 and 8 a, or any other suitable connector device. Coupling ofconnector device 15 with distal end 43 of apparatus 12 may beaccomplished via complementary threads, pressure fitting, or any othersuitable means. A common lumen 45 of connector device 15 allows passageof ultrasound transmission member 24 and is in communication withcatheter body lumen 21.

Connector device 15 may include an infusion arm 13 to allow forintroduction and/or withdrawal of one or more fluids for irrigation, dyeinjection and/or the like. Connector device 15 may further includeadditional arms, as described more fully below, for passage of a guidewire and/or passage of any other suitable structure or substance throughcatheter 10. In some embodiments, infusion arm 13 is in fluidcommunication with common lumen 45 and catheter body lumen 21. In otherembodiments, arm 13 may have a lumen that communicates with a separatelumen in connector device 15 and catheter body 22.

Generally, pressurized fluid such as an irrigant liquid may be infusedthrough infusion arm 13, common lumen 45 and catheter body lumen 21 sothat it flows out of fluid outflow apertures 36. The temperature andflow rate of such irrigant liquid may be specifically controlled tomaintain the temperature of ultrasound transmission member 24 at adesired temperature within its optimal working range and/or may enhancedisruption of blood vessel occlusions. In particular, in embodiments ofthe invention wherein ultrasound transmission member 24 is formed of ametal alloy which exhibits optimal physical properties (e.g. superelasticity) within a specific range of temperatures, the temperature andflow rate of irrigant liquid infused through infusion arm 13 may bespecifically controlled to maintain the temperature of ultrasoundtransmission member 24 within a range of temperatures at which itdemonstrates its most desirable physical properties. For example, inembodiments of the invention where ultrasound transmission member 24 isformed of a shape memory alloy which exhibits super elasticity when inits martensite state, but which loses super elasticity as it transitionsto an austenite state, it will be desirable to adjust the temperatureand flow rate of the irrigant liquid infused through infusion arm 13 soas to maintain the shape memory alloy of ultrasound transmission member24 within a temperature range at which the alloy will remain in itsmartensite state and will not transition to an austenite state. Thetemperature at which such shape memory alloys transition from amartensite state to an austenite state is known as the “martensitetransition temperature” of the material. Thus, in these embodiments, thefluid infused through arm 13 will be at such temperature, and will beinfused at such rate, as to maintain the shape memory alloy ofultrasound transmission member 24 below its martensite transitiontemperature.

Referring now to FIG. 7 a, proximal end connector apparatus 12 is shownin exploded side view. In this embodiment, sonic connector 48 is heldwithin housing 42, by means of dowel pin 50. In other embodiments, dowelpin 50 may not be included and sonic connector 48 may be positionedwithin housing by other means. Otherwise, FIG. 4 a simply demonstratesthe various components previously described with reference to FIG. 4.

With reference now to FIG. 8, in some embodiments a proximal end ofcatheter 10 may be coupled with connector device 15 that comprises aW-connector. Connector device 15 may include infusion arm 13, guidewirearm 19 and a guidewire port 140 coupled with guidewire arm 19. In someembodiments, a coupling device 142 is used for coupling connector device15 with catheter body 22. Coupling device may comprise, for example, asheath, sleeve or any other suitable device. Connector device 15 mayalso comprise any suitable connector, including any configuration ofports, lumen(s) and the like. In some embodiments, for example,guidewire arm 19 will have an angle that is as slight as possible,relative to the longitudinal axis of catheter body 22, so that only aminimal bending of a guidewire occurs when the guidewire is insertedinto guidewire arm 19 and guidewire lumen 28.

FIG. 8 a shows an exploded view of connector device 15 and a proximalportion of catheter body 22, as in FIG. 8. This view shows oneembodiment of how coupling device 142 may be used to coupled catheterbody 22 with connector device 15. In other embodiments, variousalternative coupling means may be employed without departing from thescope of the present invention.

In some embodiments, ultrasound catheter 10, one or more components ofcatheter 10 and/or one or more additional components of ultrasoundsystem 20 may be sterilized using an electron-beam sterilizationtechnique. Electron-beam sterilization techniques are known. Forexample, one may refer to “Electron-Beam Systems for Medical DeviceSterilization,” by L. R. Calhoun et al., atwww.devicelink.com/mpb/archive/97/07/002.html, the entire contents ofwhich is hereby incorporated by reference. Electron-beam radiation hasnot been applied for sterilization of devices such as ultrasoundcatheter 10 of the present invention. Such sterilization techniques mayprovide significant advantages by exposing catheter 10 to less stressthan would occur with traditional sterilization methods.

Although the invention has been described above with specific referenceto various embodiments and examples, it should be understood thatvarious additions, modifications, deletions and alterations may be madeto such embodiments without departing from the spirit or scope of theinvention. Accordingly, it is intended that all reasonably foreseeableadditions, deletions, alterations and modifications be included withinthe scope of the invention as defined in the following claims.

1. A method for treating stenosis or inhibiting restenosis at atreatment location in an artery, comprising: enhancing permeability ofthe vessel wall via the delivery of ultrasound energy to the treatmentlocation; and delivering a therapeutic agent intravenously into thehuman body.
 2. The method of claim 1, wherein ultrasound energy isdelivered to the treatment area using transcutaneous methods.
 3. Themethod of claim 1, wherein ultrasound energy is delivered to thetreatment area using endovascular catheter methods.
 4. The method ofclaim 1, wherein the therapeutic agent is delivered to the human bodyaccording to one method selected from the group consisting of: beforeultrasound energy delivery, during ultrasound energy delivery, or afterultrasound energy delivery.
 5. The method of claim 1, wherein ultrasonicenergy is delivered in one method selected from group consisting of:continuous, pulse, modulated.
 6. The method of claim 1, wherein treatingstenosis and inhibiting restenosis includes treating vulnerable plaquein an artery.
 7. A method for treating stenosis or inhibiting restenosisat a treatment location in an artery, comprising: enhancing permeabilityof the vessel wall via the delivery of ultrasound energy to thetreatment location, and delivering a therapeutic agent together with acontrast agent into the artery to the treatment location.
 8. The methodof claim 7 wherein ultrasound energy is delivered to the treatment areausing transcutaneous methods.
 9. The method of claim 7, whereinultrasound energy is delivered to the treatment area using endovascularcatheter methods.
 10. The method of claim 7, wherein the therapeuticagent is delivered to the vessel wall according to one method selectedfrom the group consisting of: before ultrasound energy delivery, duringultrasound energy delivery, after ultrasound energy delivery.
 11. Themethod of claim 7, wherein treating stenosis and inhibiting restenosisincludes treating vulnerable plaque in an artery.
 12. The method ofclaim 7, wherein treating stenosis or inhibit re-stenosis in the arteryincludes ablating or removing plaque or thrombotic material.
 13. Themethod of claim 7, wherein treating stenosis or inhibiting restenosisincludes treating a totally occluded artery.
 14. The method of claim 7,wherein treating stenosis and inhibiting restenosis includes treatingvulnerable plaque in an artery.
 15. The method of claim 7, wherein atherapeutic agent and a contrast agent are further diluted with saline.16. A method for treating an occlusion in a vessel, comprising:enhancing permeability of a wall of the vessel via the delivery ofultrasound energy to a treatment location; and delivering a medicamentintravenously into the vessel at the treatment location.
 17. The methodof claim 16, wherein ultrasound energy is delivered to the treatmentarea using transcutaneous methods.
 18. The method of claim 16, whereinultrasound energy is delivered to the treatment location usingendovascular catheter methods.
 19. The method of claim 16, wherein themedicament is delivered to the vessel according to one method selectedfrom the group consisting of: before ultrasound energy delivery, duringultrasound energy delivery, or after ultrasound energy delivery.
 20. Themethod of claim 16, wherein the frequency of the ultrasonic energy isabout 20 kHz.
 21. The method of claim 16, wherein ultrasonic energy isdelivered in one method selected from group consisting of: continuous,pulse, modulated.
 22. The method of claim 16, wherein the medicament isselected from the group consisting of: liquid, powder, particle, andcombinations thereof.
 23. The method of claim 16, further comprisingpositioning a device within the treatment area of the artery.
 24. Themethod of claim 16, wherein treating the occlusion includes treatingplaque in an artery.
 25. A method for treating an occluded artery,comprising: enhancing permeability of a wall of the artery via thedelivery of ultrasound energy to a treatment location, and delivering amedicament together with a dye into the artery at the treatmentlocation.
 26. The method of claim 25 wherein ultrasound energy isdelivered to the treatment area using transcutaneous methods.
 27. Themethod of claim 25, wherein ultrasound energy is delivered to thetreatment area using endovascular catheter methods.
 28. The method ofclaim 25, wherein the medicament is delivered to the artery wallaccording to one method selected from the group consisting of: beforeultrasound energy delivery, during ultrasound energy delivery, afterultrasound energy delivery.
 29. The method of claim 25, wherein treatingthe occlusion includes treating plaque in an artery.
 30. The method ofclaim 25, wherein treating the occlusion includes ablating or removingplaque or thrombotic material.
 31. The method of claim 25, whereintreating the occlusion includes treating a totally occluded artery. 32.The method of claim 25, further comprising positioning a device withinthe artery to prevent the medicament from a quick washout by the blood.33. The method of claim 25, wherein treating the occlusion includestreating plaque in an artery.
 34. The method of claim 25, wherein amedicament and dye are further diluted with saline.
 35. A method fortreating an occluded artery, comprising: enhancing permeability of awall of the artery via the delivery of ultrasound energy to a treatmentlocation within the artery; and delivering a medicament to the treatmentlocation using a catheter having a plurality of lumens.